Merck Sharp & Dohme Corp. has challenged Genentech’s U.S. Patent No. 7,923,221 (Cabilly III) with a complaint for declaratory judgment in the Central District of California. The patent relates to methods to produce antibody products. Merck received FDA approval to market Keytruda® (pembrolizumab) for treating certain melanomas and lung cancers, and…
The Board has instituted IPR2016-00408 and IPR2016-00409 on AbbVie Biotechnology’s U.S. Patent No. 8,889,135, which covers methods of treating rheumatoid arthritis with a human anti-tumor necrosis factor α antibody. This patent relates to AbbVie’s Humira®. IPR2016-00172 filed by Coherus BioSciences Inc. was also instituted against this patent earlier this year.
Merck Sharp & Dohme Corp. has filed an IPR petition on U.S. Patent No. 6,331,415. This patent has been challenged several times over the past year with mixed results: IPR2015-01624 (instituted); IPR2016-00383 (not instituted); IPR2016-00460 (joined with IPR2015-01624); and IPR2016-0710 (petition pending).
A preliminary review by FDA staff found that Amgen Inc.’s biosimilar of AbbVie Inc.’s Humira® showed potency and safety similar to the original product. Humira® (adalimumab) is the top-selling drug in the world and is used to treat autoimmune conditions including rheumatoid arthritis, Crohn’s disease, and ulcerative colitis. A panel…
Tuesday’s Federal Circuit opinion in Amgen v. Apotex is already being picked up and analyzed in other BPCIA litigation: in Amgen v. Hospira, Hospira has submitted the Federal Circuit’s opinion to the District Court for the District of Delaware (J. Andrews) in connection with its pending motion to dismiss Amgen’s…
As we posted yesterday, the Federal Circuit has issued its decision in Amgen v. Apotex, affirming the district court’s (S.D. Fla, J. Cohn) order preliminarily enjoining Apotex from launching its biosimilar version of Amgen’s Neulasta (pegfilgrastim) until it has received FDA licensure, given Amgen a post-licensure notice of commercial marketing, and then…
The Federal Circuit issued its decision in Amgen v. Apotex (re: Apotex’s Neulasta biosimilar) this morning. The Court affirmed the district court, holding that the commercial-marketing provision in 42 U.S.C. § 262(l)(8)(A) is mandatory and enforceable by injunction, even where the biosimilar applicant has triggered the patent dance by providing its…
AstraZeneca announced today that it has entered licensing agreements with LEO Pharma to develop and commercialize tralokinumab, a biologic that has completed a Phase IIb trial for atopic dermatitis, and brodalumab, which is under regulatory review to treat plaque psoriasis. Under the terms of the tralokinumab agreement, LEO Pharma will…
The United Kingdom’s referendum in favor of withdrawal from the European Union, colloquially known as “Brexit,” has already sent shockwaves through the business world, both within the UK, and abroad. The impact of Brexit on the pharmaceutical industry has yet to be determined, but some fear that Brexit will cause…
Back in March, 2016, the Senate added language to the FDA and NIH Workforce Authorities Modernization Act which would exempt biological products, including biosimilars, from provisions of the FDCA Act that require compliance with official compendia. This language includes compliance with the quality standards listed in the United States Pharmacopeia (USP)….